FDA 510(k)

過顎影像強化輔助設備

K 號：K241681 · 2024-09-09

決定日期2024-09-09

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

Overjet Image Enhancement Assist is the device name listed in this FDA 510(k) record. The listed applicant is Overjet, Inc.. It received FDA 510(k) clearance on 2024-09-09 under 510(k) number K241681. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Overjet Image Enhancement Assist?

Overjet Image Enhancement Assist is a medical device that received FDA 510(k) clearance on 2024-09-09. The listed applicant is Overjet, Inc.. The 510(k) number is K241681.

When did Overjet Image Enhancement Assist receive FDA 510(k) clearance?

Overjet Image Enhancement Assist received FDA 510(k) clearance on 2024-09-09, under 510(k) number K241681.

Who is the listed applicant for Overjet Image Enhancement Assist?

FDA 510(k) 記錄將 Overjet, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Overjet Image Enhancement Assist?

The FDA product code for Overjet Image Enhancement Assist is QIH.

其他以 Overjet, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：QIH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260055syngo.CT 脑量化Siemens Medical Solutions USA, Inc.K262390骨專家Visiana K261368快速平台（R6.7）Ischemaview, Inc.K261623EchoPAC 軟體僅 / EchoPAC 插件（v211）GE Medical Systems Ultrasound and Primary Care Diagnostics K261677人工智慧腎臟評估（AIRA）版本 1Aramis Global AI Consultancies, LLC K2608794DMINVIA, LLC

官方來源

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